(1) Partial amendment to the Minimum Requirements for Biological Products (2) Partial amendment to the Public Notice on National Release Testing (1 page(s), in English)
Distribution date: 07 March 2022 | Final date for Comment: 06 April 2022
(1) The Minimum Requirements for Biological Products will be partially amended to add the standard for a vaccine product to be newly approved. (2) The fee, criterion and test sample quantity for National Release Testing will be partially amended to provide for the above-mentioned vaccine product.
Products Covered: (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Proposed amendments to The Korean Pharmacopoeia
Distribution date: 10 March 2022 | Final date for Comment: 09 May 2022
The purpose of the revision is to secure pharmaceutical quality control based on achieved international harmonization of criteria/specification in Korean Pharmacopoeia, to improve some criteria/specifications and general tests to the latest scientific level with reflecting opinions from the pharmaceutical industries, ultimately, to advance criteria/specifications and circulate high quality pharmaceuticals. A. To improve test’s accuracy including accurate calibration and dissolution test (changed from fluorometry or ultraviolet-visible spectrophotometry to chromatography (High Performance Liquid Chromatography)) B. To improve process on test solutions and reference solutions based on solubility. To utilize spectrometry (Infrared Spectroscopy) and chromatography instead of quantitative test
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 February 2022 | Final date for Comment: 07 May 2025
The proposed maximum residue limits (MRLs) for Flazasulfuron notified in G/SPS/N/JPN/843 (dated 26 May 2021) were adopted and published on 19 October 2021. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022 | Final date for Comment: 07 May 2025
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Benthiavalicarb-isopropyl.
Products Covered: - Natural honey (HS Code: 04.09) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.04, 08.05, 08.06, 08.07, 08.10, 08.11 and 08.14) - Spices (HS Codes: 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07)
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 February 2022 | Final date for Comment: 07 May 2025
The proposed maximum residue limits (MRLs) for Tolfenpyrad notified in G/SPS/N/JPN/844 (dated 26 May 2021) were adopted and published on 19 October 2021. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 February 2022 | Final date for Comment: 07 May 2025
The proposed maximum residue limits (MRLs) for Isometamidium notified in G/SPS/N/JPN/848 (dated 26 May 2021) were adopted and published on 19 October 2021. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022 | Final date for Comment: 13 May 2022
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Polyoxorim-zinc.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.09 and 07.10) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.06) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.07 and 12.12)
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 February 2022 | Final date for Comment: 07 May 2025
The proposed maximum residue limits (MRLs) for Fenpropathrin notified in G/SPS/N/JPN/835 (dated 1 April 2021) were adopted and published on 31 August 2021. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022 | Final date for Comment: 13 May 2022
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Polyoxin complex.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.09 and 07.10) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.06) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.07 and 12.12)
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 February 2022 | Final date for Comment: 07 May 2025
The proposed maximum residue limits (MRLs) for Eugenol notified in G/SPS/N/JPN/847 (dated 26 May 2021) were adopted and published on 19 October 2021. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
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